GMP Cleanroom Production Operator II

Orano Med, LLC.; Brownsburg (IN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive compensation

Health, Dental, and Vision insurance -

401(k) with employer matching

Life insurance

Short- and Long-Term Disability

Generous Paid Time Off

Training and Development opportunities

and more...

Job summary

Orano Med, LLC. seeks a Production Operator II to drive routine production in a new facility, ensuring aseptic processes and regulatory compliance.

The role emphasizes collaboration with QC/QA, writing and reviewing SOPs, and maintaining audit readiness in a fast-paced environment. You will perform cleanroom activities, gowning, routine disinfection, and materials handling while adhering to EHS guidelines and GMP standards.

Qualifications

• Associate's degree or 60 college credit hours with 2+ years GMP/quality or production experience.
• High School Diploma with 3+ years in GMP quality or production.
• Hands-on GMP production of sterile pharmaceuticals 2+ yrs.
• Cleanroom operations: gowning, cleaning, EM, aseptic technique.
• Follow SOPs and detailed documentation (batch records).
• QMS in regulated environments: QA, GDP, SOPs, document control.
• Ability to work in a fast-paced, high-pressure environment with deadlines.
• Attention to detail; meticulous execution.
• Excellent written and verbal English.

Responsibilities

• Improve processes with management to boost efficiency.
• Train team members and lead by example.
• Write and review SOPs.
• Maintain batch records and equipment logs.
• Ensure regulatory compliance and audit readiness.
• Perform routine cleanings of cleanroom suites.
• Support deviations, CAPAs, change controls.
• Collaborate with QC/QA to ensure product quality.

Skills

Strong problem-solving

Prioritize tasks

Excellent written and verbal English

Detail-oriented

Team participation with leadership

Fast-paced, high-pressure adaptation

Education

Associate's degree or 60 college credit hours with 2+ years GMP/quality or production experience

High School Diploma with 3+ years GMP experience

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Database software

Job description

Orano Med, LLC. seeks a Production Operator II to drive routine production in a new facility, ensuring aseptic processes and regulatory compliance.

The role emphasizes collaboration with QC/QA, writing and reviewing SOPs, and maintaining audit readiness in a fast-paced environment. You will perform cleanroom activities, gowning, routine disinfection, and materials handling while adhering to EHS guidelines and GMP standards.